10 ms·

FDA authorizes first antiviral pill for Covid, Paxlovid

jagraff 5y ago
This is huge. ~90% decrease in hospitalization rate could mean that we no longer have to worry about COVID spikes filling up hospitals, one of the biggest issues during the pandemic. This could make COVID like the flu - something to avoid, but not something that's so dangerous that we shut down our lives to avoid it.
- resoluteteeth 5y ago
  It's extremely promising, but unfortunately it's going to take a while before there's enough to go around, so there may not be that much effect immediately. However, as long as covid doesn't mutate in a way that makes this pill ineffective (I don't know whether that's possible or not?) it could eventually effectively end the pandemic once they have enough doses.
- JPKab 5y ago
  Correct. For the vast majority of the population, COVID is already like the flu, but as you pointed out, a large enough percentage of the population (particularly obese/elderly/immune compromised) of people who contract it are at risk of hospitalization that it creates a lot of anxiety about hospital capacity. We're currently getting two pieces of good news on COVID: This pill, and perhaps more importantly for the majority of people on the planet who won't have the ability to get this pill, the data on Omicron is currently showing a divergence (compared to previous waves) of cases and deaths. This divergence is rather apparent by looking at graphs of South Africa. Previous spikes in cases resulted in corresponding (lagging by a few days) spikes in deaths. Omicron isn't showing this. Click between cases and deaths on this chart to see for yourself: https://ig.ft.com/coronavirus-chart/?areas=usa&areas=zaf&areasRegional=usny&areasRegional=usfl&areasRegional=usct&areasRegional=usor&areasRegional=usga&cumulative=0&logScale=0&per100K=1&startDate=2020-01-01&values=cases https://ig.ft.com/coronavirus-chart/?areas=usa&areas=zaf&are...
  - jdavis703 5y ago
    Most of the American population is overweight* or has some other comorbidity like diabetes or high blood pressure. * Many public health authorities consider being overweight (and just obese) to be a risk factor.
    - JPKab 5y ago
      The numbers are the numbers. # of hospitalizations/# of cases is not a high number. It doesn't have to be a high number to overwhelm hospitals, I get that. But it's still a small percentage. When I caught it in February, before I was eligible for the vaccine, I was shocked by the reaction of most of my peers. They seemed surprised by my mild symptoms. The American public, as a whole, overestimates their own risk of hospitalization by orders of magnitude. You can be angry at me for recklessly stating this, and not piously pretending like the risk is evenly spread, but I'm not going to join in a mass delusion of pretending like 15 year old kids are statistically at risk from this virus. They aren't. The distributions of cases and deaths by age group on this CDC dashboard are striking: https://covid.cdc.gov/covid-data-tracker/#demographics https://covid.cdc.gov/covid-data-tracker/#demographics
  - sergiotapia 5y ago
    Precisely why I started a strict 1800 calorie cutting diet and working out six times a week. Already down 11kg. Obesity makes you severely at risk yet it's not really highlighted by the news. They make it seem like everybody is at severe risk. If anyone else wants to lose weight, it's simple but very difficult. It will test your discipline. Find out your TDEE using this https://tdeecalculator.net/ https://tdeecalculator.net/, subtract 500 and boom that's your ceiling. Don't eat anything beyond that. Use myfitnesspal to track calories and weigh your food using a scale. That simple. If you work out you will lose weight even quicker. You will succeed or fail in the kitchen. The gym is just gravy on top - fight your battle in the kitchen. It's simple but _very_ difficult. Easily the hardest thing I've done in my life.
    - inglor_cz 5y ago
      It is my understanding that most weight loss attempts are rather successful at the beginning (several weeks), they tend to slide towards a plateau in a few months and it is a real challenge not to gain the lost weight back in a year or two. Long term success rate seems to be around 20 per cent. [0] At the risk of sounding stupid or glib, the best strategy is "not to play", e.g. never gain the extra weight in the first place. Which may not be feasible for people who grow up in fat families and already reach adulthood as obese. But the still-nonobese people should be vigilant. [0] ... https://pubmed.ncbi.nlm.nih.gov/16002825/ https://pubmed.ncbi.nlm.nih.gov/16002825/
- absurddoctor 5y ago
  Isn’t it still the case that a large percentage of hospitalizations are people who refused to get vaccinated? Is there any reason to believe these same folks would willingly take this?
  - kenjackson 5y ago
    The people who refuse vaccines don't do it for a really strong principled reason, AFAICT. I think they compartmentalize vaccines and the industry that makes them completely distinct from the rest of the pharma industry. Even more than that they view the Covid vaccine differently than flu or any other vaccine - largely for political reasons.
    - guerrilla 5y ago
      Some do, some don't. I know two anti-vaxxers and one of them takes medication for mental illness and the other doesn't trust any doctors for any reason but does all kinds of homeopathy and other psuedoscientific shit.
    - throwawayboise 5y ago
      I think people who refuse or are reluctant to be vaccinated do it for a variety of reasons. Some (I think a minority) are some degree of conspiracy nuts who think it's all a plot to reduce population and enable government mind control via altered DNA, etc. Some don't trust that the speed of the process as well as the immense political pressure to "do something" really sussed out the true effectiveness, safety, and immunity conferred by the vaccines, noting that coronaviruses have never had successful vaccines before now, as they mutate too rapidly. I'm in the second camp. I viewed the situation as entirely different from traditional, well studied vaccines for endemic diseases such as measles, mumps, etc. I eventually did get vaccinated as I was under threat to lose my job if I didn't. I didn't want it otherwise, and time has shown that they aren't nearly as effective as initially promised. Most of the initial promises that the vaccines were the key to ending the pandemic have turned out to be wrong, the only thing we can really now say is that they offer some (short-term?) protection to the recipient, and at least in the case of the Janssen/J&J vaccine they are not as safe as promised either. I will add that I don't like doctors, and I'm not a pill-popper. I don't take medicines that I don't need. I would be loathe to take any long-term prescription meds for any reason. Short term courses of antibiotics I will use. Other OTC very sparingly. I don't think I've taken more than a few Advils in the past 5 years, and that was when I had a tooth extracted.
- potiuper 5y ago
  Unlikely until adequate testing supplies are available that may be resolved next year. By the time a case shows up at the hospital the infection is no longer being driven by viral replication. At that point inflammatory responses, like those dampened by the anti-IL-6 receptor antibody tocilizumab, dominate. https://www.nature.com/articles/d41573-021-00202-8 https://www.nature.com/articles/d41573-021-00202-8
  - rapjr9 5y ago
    Supply is also an issue, see this article by Dr. Eric Topol: https://www.theguardian.com/commentisfree/2021/dec/21/paxlovid-anti-covid-pill-why-not-available https://www.theguardian.com/commentisfree/2021/dec/21/paxlov... It seems strange that large scale manufacturing appears to have not even been started yet, the projections for 2022 are only for 200M treatment courses (the latest announcement, at the time of the above article the projection was 80M). Biden is in the process of implementing some measures to make testing more available, but it is going to take some time and looks rather inadequate (500M free tests would last maybe a few weeks with everyone in the USA doing regular testing? Maybe they'd last a lot longer if everyone only did symptomatic testing, although regular testing is required in some places which will use up a lot of tests). But unless manufacturing is ramped up quickly the supply of this drug is going to be very low. The USA has prepurchased only 10M treatment courses. So we won't be able to just give it to anyone (at 168,409 cases per day 10M treatment courses would only last 59 days). But you can't tell yet who will get seriously ill and Paxlovid treatment has to start when symptoms start (and the number of people with symptoms may be much higher than the current case/day count). So someone is going to have to decide who lives and who dies. For older or immunocompromised people this is likely an easy choice and will be a boon. For younger, healthier people this may not be an option at all until supply becomes much larger. Pfizer said they were going to help manufacturers make Paxlovid locally so that all countries would have access to it, license free. What is the status of those efforts? It seems to take 9 months to manufacture: https://www.india.com/news/world/pfizer-pill-paxlovid-becomes-first-us-authorized-home-covid-treatment-5151345/ https://www.india.com/news/world/pfizer-pill-paxlovid-become... "Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year." So Paxlovid may be the beginning of the end of COVID-19, but it seems it is not going to happen quickly. Certainly not in time for much use with Omicron.
6d6b73 5y ago
laluser 5y ago
>The drug, which belongs to a family called protease inhibitors, doesn't target the virus' spike protein, as the vaccines do. Apparently, only one of the three available monoclonal antibodies seem to be effective against Omicron at the moment, so this can't come soon enough. How is Pfizer so successful in this space at the moment?
dimitar 5y ago
[flagged]
- vkou 5y ago
  > People refuse vaccines because they are experimental - will they believe an even newer drug? They don't refuse vaccines because they are 'experimental'[1] (They are happy to demand vitamin C, or ivermectin, etc, etc, etc.), they refuse them because it's the position their political tribe has adopted. [1] They've gone through all the same human trials as any other vaccine - it's just that they went through those trials at the same time, as opposed to one-after-the-other.
  - fatcat500 5y ago
    Vitamin C and Ivermectin aren't experimental. I'm not against the vaccine, but to say that an emergency approved drug is as circumspect as older drugs (e.g. Ivermectin was approved as early as the 1980s) is misleading. That being said, I still think it's the right move to take the vaccine because the statistics show that it is effective.
    - wetpaws 5y ago
      >e.g. Ivermectin was approved as early as the 1980 Pretty sure it haven't been approved for covid in 1980
  - elric 5y ago
    Reducing vaccine rejection down to "political tribalism" is probably wrong and definitely not helpful. There are people across the entire political spectrum who refuse vaccines, and this is pretty much a global phenomenon.
  - vladgur 5y ago
    In my anecdotal experience, vaccine hesitancy, or whatever you call it, cannot be attributed to a party allegiance in the US. There are as many if not more liberal vaccine refusers as there are conservative ones
jaredhansen 5y ago
About damn time.
ed25519FUUU 5y ago
[flagged]
endisneigh 5y ago
At this point all Covid restrictions need to be gone. It’s time to go back to normal. Triple vaxxed people are not dying and are barely being hospitalized. Kids can be vaccinated and now there’s antiviral pills. All empirical data shows that if you’re boosted you’re fine. It’s over. It’s time to stop listening to Doomer politicians and bureaucrats until vaccinated people start dying at rates similar to March 2020.
- josefresco 5y ago
  Over?! Anecdotally my local hospital is full and a neighboring state had to call up the National Guard. Maybe not the same crisis level of 2020, but it's far from "over".
  - endisneigh 5y ago
    Yes I’m sure it’s full of people who failed to vaccinate themselves or those whose spots were taken by anti vaxxers.
    - deleted 5y ago
      [deleted]
  - Reichhardt 5y ago
    Hospitals fill up every winter from respiratory viruses. The healthcare system is designed to fill up. There's no point having expensive rooms, machines, and staff sitting idle. Planners forecast seasonal requirements and build healthcare around the maximum. We're probably going to see increased demands on hospitals simply due to the larger numbers of old people. For example, 2009 Swine Flu (remember that?) is about as deadly as 2020 COVID. But now in eg. the USA, there are 2.9m 80-84 year old men (elderly men are in the prime risk category for COVID deaths), compared to 2.3m in 2009: https://www.populationpyramid.net/united-states-of-america/2009/ https://www.populationpyramid.net/united-states-of-america/2... These demographic trends were exacerbated by weak flu seasons in 2018 and 2019. Crises always bring light to pre-existing failures in systems. COVID is simply exposing Western societies as aged, overweight, and Vitamin-D deficient.
usaphp 5y ago
> It's taken twice a day for five days in combination with a second medicine called Ritonavir hmm I wonder what changed since they discontinued the other Ritonavir treatment: https://www.who.int/news/item/04-07-2020-who-discontinues-hydroxychloroquine-and-lopinavir-ritonavir-treatment-arms-for-covid-19 https://www.who.int/news/item/04-07-2020-who-discontinues-hy...
HarryHirsch 5y ago
Are all of us who teach at universities supposed to take pre-exposure prophylaxis before setting feet into a lecture theater? How about some lifestyle changes? Why is proper ventilation never discussed?
ratsmack 5y ago
For anyone curious, here's some info comparing Paxlovid with Ivermectin: https://www.acsh.org/news/2021/12/02/how-does-pfizers-paxlovid-compare-ivermectin-15967 https://www.acsh.org/news/2021/12/02/how-does-pfizers-paxlov...
- deleted 5y ago
  [deleted]

This is huge. ~90% decrease in hospitalization rate could mean that we no longer have to worry about COVID spikes filling up hospitals, one of the biggest issues during the pandemic. This could make COVID like the flu - something to avoid, but not something that's so dangerous that we shut down our lives to avoid it.

resoluteteeth 5y ago
It's extremely promising, but unfortunately it's going to take a while before there's enough to go around, so there may not be that much effect immediately. However, as long as covid doesn't mutate in a way that makes this pill ineffective (I don't know whether that's possible or not?) it could eventually effectively end the pandemic once they have enough doses.
JPKab 5y ago
Correct. For the vast majority of the population, COVID is already like the flu, but as you pointed out, a large enough percentage of the population (particularly obese/elderly/immune compromised) of people who contract it are at risk of hospitalization that it creates a lot of anxiety about hospital capacity. We're currently getting two pieces of good news on COVID: This pill, and perhaps more importantly for the majority of people on the planet who won't have the ability to get this pill, the data on Omicron is currently showing a divergence (compared to previous waves) of cases and deaths. This divergence is rather apparent by looking at graphs of South Africa. Previous spikes in cases resulted in corresponding (lagging by a few days) spikes in deaths. Omicron isn't showing this. Click between cases and deaths on this chart to see for yourself: https://ig.ft.com/coronavirus-chart/?areas=usa&areas=zaf&areasRegional=usny&areasRegional=usfl&areasRegional=usct&areasRegional=usor&areasRegional=usga&cumulative=0&logScale=0&per100K=1&startDate=2020-01-01&values=cases https://ig.ft.com/coronavirus-chart/?areas=usa&areas=zaf&are...
- jdavis703 5y ago
  Most of the American population is overweight* or has some other comorbidity like diabetes or high blood pressure. * Many public health authorities consider being overweight (and just obese) to be a risk factor.
  - JPKab 5y ago
    The numbers are the numbers. # of hospitalizations/# of cases is not a high number. It doesn't have to be a high number to overwhelm hospitals, I get that. But it's still a small percentage. When I caught it in February, before I was eligible for the vaccine, I was shocked by the reaction of most of my peers. They seemed surprised by my mild symptoms. The American public, as a whole, overestimates their own risk of hospitalization by orders of magnitude. You can be angry at me for recklessly stating this, and not piously pretending like the risk is evenly spread, but I'm not going to join in a mass delusion of pretending like 15 year old kids are statistically at risk from this virus. They aren't. The distributions of cases and deaths by age group on this CDC dashboard are striking: https://covid.cdc.gov/covid-data-tracker/#demographics https://covid.cdc.gov/covid-data-tracker/#demographics
- sergiotapia 5y ago
  Precisely why I started a strict 1800 calorie cutting diet and working out six times a week. Already down 11kg. Obesity makes you severely at risk yet it's not really highlighted by the news. They make it seem like everybody is at severe risk. If anyone else wants to lose weight, it's simple but very difficult. It will test your discipline. Find out your TDEE using this https://tdeecalculator.net/ https://tdeecalculator.net/, subtract 500 and boom that's your ceiling. Don't eat anything beyond that. Use myfitnesspal to track calories and weigh your food using a scale. That simple. If you work out you will lose weight even quicker. You will succeed or fail in the kitchen. The gym is just gravy on top - fight your battle in the kitchen. It's simple but _very_ difficult. Easily the hardest thing I've done in my life.
  - inglor_cz 5y ago
    It is my understanding that most weight loss attempts are rather successful at the beginning (several weeks), they tend to slide towards a plateau in a few months and it is a real challenge not to gain the lost weight back in a year or two. Long term success rate seems to be around 20 per cent. [0] At the risk of sounding stupid or glib, the best strategy is "not to play", e.g. never gain the extra weight in the first place. Which may not be feasible for people who grow up in fat families and already reach adulthood as obese. But the still-nonobese people should be vigilant. [0] ... https://pubmed.ncbi.nlm.nih.gov/16002825/ https://pubmed.ncbi.nlm.nih.gov/16002825/
absurddoctor 5y ago
Isn’t it still the case that a large percentage of hospitalizations are people who refused to get vaccinated? Is there any reason to believe these same folks would willingly take this?
- kenjackson 5y ago
  The people who refuse vaccines don't do it for a really strong principled reason, AFAICT. I think they compartmentalize vaccines and the industry that makes them completely distinct from the rest of the pharma industry. Even more than that they view the Covid vaccine differently than flu or any other vaccine - largely for political reasons.
  - guerrilla 5y ago
    Some do, some don't. I know two anti-vaxxers and one of them takes medication for mental illness and the other doesn't trust any doctors for any reason but does all kinds of homeopathy and other psuedoscientific shit.
  - throwawayboise 5y ago
    I think people who refuse or are reluctant to be vaccinated do it for a variety of reasons. Some (I think a minority) are some degree of conspiracy nuts who think it's all a plot to reduce population and enable government mind control via altered DNA, etc. Some don't trust that the speed of the process as well as the immense political pressure to "do something" really sussed out the true effectiveness, safety, and immunity conferred by the vaccines, noting that coronaviruses have never had successful vaccines before now, as they mutate too rapidly. I'm in the second camp. I viewed the situation as entirely different from traditional, well studied vaccines for endemic diseases such as measles, mumps, etc. I eventually did get vaccinated as I was under threat to lose my job if I didn't. I didn't want it otherwise, and time has shown that they aren't nearly as effective as initially promised. Most of the initial promises that the vaccines were the key to ending the pandemic have turned out to be wrong, the only thing we can really now say is that they offer some (short-term?) protection to the recipient, and at least in the case of the Janssen/J&J vaccine they are not as safe as promised either. I will add that I don't like doctors, and I'm not a pill-popper. I don't take medicines that I don't need. I would be loathe to take any long-term prescription meds for any reason. Short term courses of antibiotics I will use. Other OTC very sparingly. I don't think I've taken more than a few Advils in the past 5 years, and that was when I had a tooth extracted.
potiuper 5y ago
Unlikely until adequate testing supplies are available that may be resolved next year. By the time a case shows up at the hospital the infection is no longer being driven by viral replication. At that point inflammatory responses, like those dampened by the anti-IL-6 receptor antibody tocilizumab, dominate. https://www.nature.com/articles/d41573-021-00202-8 https://www.nature.com/articles/d41573-021-00202-8
- rapjr9 5y ago
  Supply is also an issue, see this article by Dr. Eric Topol: https://www.theguardian.com/commentisfree/2021/dec/21/paxlovid-anti-covid-pill-why-not-available https://www.theguardian.com/commentisfree/2021/dec/21/paxlov... It seems strange that large scale manufacturing appears to have not even been started yet, the projections for 2022 are only for 200M treatment courses (the latest announcement, at the time of the above article the projection was 80M). Biden is in the process of implementing some measures to make testing more available, but it is going to take some time and looks rather inadequate (500M free tests would last maybe a few weeks with everyone in the USA doing regular testing? Maybe they'd last a lot longer if everyone only did symptomatic testing, although regular testing is required in some places which will use up a lot of tests). But unless manufacturing is ramped up quickly the supply of this drug is going to be very low. The USA has prepurchased only 10M treatment courses. So we won't be able to just give it to anyone (at 168,409 cases per day 10M treatment courses would only last 59 days). But you can't tell yet who will get seriously ill and Paxlovid treatment has to start when symptoms start (and the number of people with symptoms may be much higher than the current case/day count). So someone is going to have to decide who lives and who dies. For older or immunocompromised people this is likely an easy choice and will be a boon. For younger, healthier people this may not be an option at all until supply becomes much larger. Pfizer said they were going to help manufacturers make Paxlovid locally so that all countries would have access to it, license free. What is the status of those efforts? It seems to take 9 months to manufacture: https://www.india.com/news/world/pfizer-pill-paxlovid-becomes-first-us-authorized-home-covid-treatment-5151345/ https://www.india.com/news/world/pfizer-pill-paxlovid-become... "Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year." So Paxlovid may be the beginning of the end of COVID-19, but it seems it is not going to happen quickly. Certainly not in time for much use with Omicron.

6d6b73 5y ago

laluser 5y ago

>The drug, which belongs to a family called protease inhibitors, doesn't target the virus' spike protein, as the vaccines do. Apparently, only one of the three available monoclonal antibodies seem to be effective against Omicron at the moment, so this can't come soon enough. How is Pfizer so successful in this space at the moment?

dimitar 5y ago

[flagged]

vkou 5y ago
> People refuse vaccines because they are experimental - will they believe an even newer drug? They don't refuse vaccines because they are 'experimental'[1] (They are happy to demand vitamin C, or ivermectin, etc, etc, etc.), they refuse them because it's the position their political tribe has adopted. [1] They've gone through all the same human trials as any other vaccine - it's just that they went through those trials at the same time, as opposed to one-after-the-other.
- fatcat500 5y ago
  Vitamin C and Ivermectin aren't experimental. I'm not against the vaccine, but to say that an emergency approved drug is as circumspect as older drugs (e.g. Ivermectin was approved as early as the 1980s) is misleading. That being said, I still think it's the right move to take the vaccine because the statistics show that it is effective.
  - wetpaws 5y ago
    >e.g. Ivermectin was approved as early as the 1980 Pretty sure it haven't been approved for covid in 1980
- elric 5y ago
  Reducing vaccine rejection down to "political tribalism" is probably wrong and definitely not helpful. There are people across the entire political spectrum who refuse vaccines, and this is pretty much a global phenomenon.
- vladgur 5y ago
  In my anecdotal experience, vaccine hesitancy, or whatever you call it, cannot be attributed to a party allegiance in the US. There are as many if not more liberal vaccine refusers as there are conservative ones

jaredhansen 5y ago

About damn time.

ed25519FUUU 5y ago

[flagged]

endisneigh 5y ago

At this point all Covid restrictions need to be gone. It’s time to go back to normal. Triple vaxxed people are not dying and are barely being hospitalized. Kids can be vaccinated and now there’s antiviral pills. All empirical data shows that if you’re boosted you’re fine. It’s over. It’s time to stop listening to Doomer politicians and bureaucrats until vaccinated people start dying at rates similar to March 2020.

josefresco 5y ago
Over?! Anecdotally my local hospital is full and a neighboring state had to call up the National Guard. Maybe not the same crisis level of 2020, but it's far from "over".
- endisneigh 5y ago
  Yes I’m sure it’s full of people who failed to vaccinate themselves or those whose spots were taken by anti vaxxers.
  - deleted 5y ago
    [deleted]
- Reichhardt 5y ago
  Hospitals fill up every winter from respiratory viruses. The healthcare system is designed to fill up. There's no point having expensive rooms, machines, and staff sitting idle. Planners forecast seasonal requirements and build healthcare around the maximum. We're probably going to see increased demands on hospitals simply due to the larger numbers of old people. For example, 2009 Swine Flu (remember that?) is about as deadly as 2020 COVID. But now in eg. the USA, there are 2.9m 80-84 year old men (elderly men are in the prime risk category for COVID deaths), compared to 2.3m in 2009: https://www.populationpyramid.net/united-states-of-america/2009/ https://www.populationpyramid.net/united-states-of-america/2... These demographic trends were exacerbated by weak flu seasons in 2018 and 2019. Crises always bring light to pre-existing failures in systems. COVID is simply exposing Western societies as aged, overweight, and Vitamin-D deficient.

usaphp 5y ago

> It's taken twice a day for five days in combination with a second medicine called Ritonavir hmm I wonder what changed since they discontinued the other Ritonavir treatment: https://www.who.int/news/item/04-07-2020-who-discontinues-hydroxychloroquine-and-lopinavir-ritonavir-treatment-arms-for-covid-19 https://www.who.int/news/item/04-07-2020-who-discontinues-hy...

HarryHirsch 5y ago

Are all of us who teach at universities supposed to take pre-exposure prophylaxis before setting feet into a lecture theater? How about some lifestyle changes? Why is proper ventilation never discussed?

ratsmack 5y ago

For anyone curious, here's some info comparing Paxlovid with Ivermectin: https://www.acsh.org/news/2021/12/02/how-does-pfizers-paxlovid-compare-ivermectin-15967 https://www.acsh.org/news/2021/12/02/how-does-pfizers-paxlov...

deleted 5y ago
[deleted]